Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages 18 and up

Comparing early proton pump inhibitor use to standard care for kidney injury in trauma patients

Official title: Comparison of Early Proton Pump Inhibitor Initiation Versus Usual Care on Acute Kidney Injury (CEPU-AKI) in Hemorrhagic Shock Patients: A Prospective Randomized Controlled Trial

Run by The University of Texas Health Science Center, Houston · NCT06531642 · Data updated 2026-11-12

This study is testing if giving the heartburn medication pantoprazole early can help prevent kidney injury in trauma patients who are in shock.

More Acute Kidney Injury trials

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorThe University of Texas Health Science Center, Houston
Academic / other
Locations1 site (Houston, Texas)
StatusRecruiting
StartedSeptember 7, 2024
Main results expectedJuly 31, 2026
Study endsSeptember 1, 2026
Registry record updatedFebruary 19, 2026
Trial IDNCT06531642 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults over 18 years old who meet the criteria for hemorrhagic shock due to traumatic acute bleeding.

Probably not a fit

Patients under 18 years of age, those on renal replacement therapy, or with a history of PPI sensitivity may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate whether the early initiation of the proton pump inhibitor pantoprazole can reduce the incidence of acute kidney injury (AKI) in trauma patients experiencing hemorrhagic shock. It is a single-center, randomized, controlled trial involving 100 adult patients who will be assigned to receive either early or routine administration of pantoprazole for two days following their injury. The study will assess kidney injury through urinary biomarkers and track the incidence and severity of AKI, as well as major adverse kidney events over a 30-day period. The findings could provide insights into optimizing treatment protocols for trauma patients at risk of kidney damage.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of acute kidney injury in trauma patients, leading to better outcomes and reduced mortality.

How similar studies have gone: While the specific approach of early PPI use in this context may be novel, similar studies have indicated potential benefits of early intervention in reducing organ damage in trauma patients.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Adult patient (≥18 years of age)
* Patient meets hemorrhagic shock criteria:
* Hypovolemic shock from traumatic acute bleeding
* Systolic blood pressure ≤ 90 mmHg AND tachycardia (HR ≥ 108) at presentation to the ED; OR
* Systolic blood pressure ≤ 70 mmHg at presentation to the ED.

Exclusion Criteria:

* Patients \<18 years of age
* Patients known to be actively on renal replacement therapy
* Cardiac arrest prior to ED arrival or who are deemed to have expected survival of less than 24 hours
* History of PPI sensitivity or allergy
* Patient who are already enrolled in other trials prior to ED arrival and these trials do not allow co-enrollment
* Patient who presents with ongoing GI bleeding that will require higher dose of GI prophylaxis
* Vulnerable populations such as pregnant women and prisoners

Where it's running

  • Memorial Hermann Texas Medical Center
    Houston, Texas, United States
    Recruiting

Study contacts

  • Principal investigator: Yafen Liang, MD — The University of Texas Health Science Center, Houston
  • Study coordinator: Yafen Liang, MD
  • Email: yafen.liang@uth.tmc.edu
  • Phone: 713-500-6226

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.